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AG-348

DRUG9 trials

Sponsors

Agios Pharmaceuticals, Inc., National Institutes of Health Clinical Center (CC)

Conditions

Anemia, HemolyticHealthyHealthy VolunteerHealthy VolunteersJapaneseNon-AsianPyruvate Kinase DeficiencySickle Cell Disease

Early Phase 1

A Dose-Finding Study of AG-348 in Sickle Cell Disease
CompletedNCT04000165
National Institutes of Health Clinical Center (CC)Sickle Cell Disease
Start: 2019-07-11End: 2021-06-21Updated: 2022-07-12

Phase 1

A Phase I Study of AG-348 in Healthy Volunteers
CompletedNCT02108106
Agios Pharmaceuticals, Inc.Healthy Volunteer
Start: 2014-03-31End: 2014-08-31Updated: 2014-10-22
A Phase I Study of AG-348 in Healthy Volunteers
CompletedNCT02149966
Agios Pharmaceuticals, Inc.Healthy Volunteer
Start: 2014-05-31End: 2014-11-30Updated: 2014-11-10
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
CompletedNCT03250598
Agios Pharmaceuticals, Inc.Healthy, Japanese, Non-Asian
Start: 2017-08-09End: 2017-10-09Updated: 2017-10-19
A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348
CompletedNCT03703505
Agios Pharmaceuticals, Inc.Healthy Volunteers
Start: 2018-05-24End: 2018-06-04Updated: 2018-10-12

Phase 2

A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency
CompletedNCT02476916
Agios Pharmaceuticals, Inc.Pyruvate Kinase Deficiency
Start: 2015-06-26End: 2025-04-02Updated: 2026-05-01
A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia
Active, not recruitingNCT03692052
Agios Pharmaceuticals, Inc.Thalassemia
Start: 2019-03-20End: 2030-09-30Updated: 2026-03-30

Phase 3

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)
CompletedNCT03548220
Agios Pharmaceuticals, Inc.Anemia, Hemolytic, Pyruvate Kinase Deficiency
Start: 2018-08-09End: 2020-10-09Updated: 2022-05-24
A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)
CompletedNCT03559699
Agios Pharmaceuticals, Inc.Anemia, Hemolytic, Pyruvate Kinase Deficiency
Start: 2018-06-26End: 2020-11-12Updated: 2022-01-04

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